Get Generic Drug Labeling Revisions Covered Under Section 505j10 Of The Federal Food Drug And Cosmetic
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(a) Section 520(l )(2) of the Federal Food, Drug, and Cosmetic Act applies to reclassification proceedings initiated by the Commissioner or in response to a request by a manufacturer or importer for reclassification of a device currently in class III by operation of section 520(l )(1).
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